Light therapy has been used previously to treat ulcers and wounds as well as to disinfect surfaces that come into contact with ulcers and wounds or other parts of a patient's body. Ulcers or wounds on the body take time to heal. Some of the wounds are caused by compounding factors such as blood flow occlusion due to high pressures (pressure ulcers), or diabetes etc. Traditional treatments include, negative pressure therapy, medications etc. The challenge with traditional treatments is that if the source of the problem is not addressed the treatments are less effective. For example in the case of sacral pressure ulcers, if the treatment is not coupled with a lower pressure solution the problem will not be solved.
Aside from the use of light therapy to treat ulcers and wounds, light therapy has also been used to disinfect surfaces that come into contact with the ulcers and wounds. For instance, hospital mattresses are generally covered with a cover. A medical bed mattress cover provides outer protection to a medical bed mattress by preventing blood and body fluids from entering the inside (inner core) of the mattress. Types of mattresses may include alternating pressure (ac-powered) air flotation mattresses, non-powered flotation mattresses, and other mattresses that are part of hospital beds. Medical bed mattress covers may be coated with or contain a substance that kills germs (e.g., viruses or bacteria) or prevents bacterial growth. There are multiple terms used to describe medical bed mattress covers: water-resistant (e.g., keeps liquid away from the material), water-proof (e.g., prevents liquid from entering inside the material), or water-repellent (e.g., keeps liquid away from the material and prevents liquid from entering inside the material).
The FDA typically receives reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.
Medical literature shows that damaged and wet (soiled) mattresses can be a source of contamination during infection outbreaks. The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and caregivers.
In order to decontaminate mattresses, the covers can be removed and the mattresses aerated; however, doing so is labor intensive and time consuming. Alternatively, light can be illuminated in the entire room or directly upon a mattress; however, simple exposure to light may not kill all bacteria and may not reach below the covers to a required depth.
Accordingly, there exists a need for treatment devices and methods which can facilitate the healing of ulcers or wounds without occluding blood flow to the body regions as well as disinfect surfaces that may come into contact with the ulcers or wounds or other body portions.